The US Food and Drug Administration (FDA) has updated its guidance regarding how it regulates certain health-related technology.
Under the revised guidance, a product may be classified as a general wellness product – rather than a regulated medical device – if it is intended to maintain or encourage a general state of health, or if it relates a healthy lifestyle to reducing the risk or impact of certain chronic diseases or conditions.
Among the examples cited by the FDA are wrist-worn wearable devices designed to assess multiple biomarkers, such as sleep duration, sleep quality, pulse rate and blood pressure. However, the guidance makes clear that if a product’s claims suggest use in a medical or clinical context – such as diagnosing, treating or managing a disease – it would no longer be considered a low-risk general wellness product and would remain subject to FDA regulation.
In a second guidance, the FDA announced changes to its approach to regulating clinical decision support (CDS) software. The agency indicated that certain types of software may resemble medical tools but are considered sufficiently low risk to fall outside active FDA oversight, provided they remain within defined boundaries.
In the guidance the FDA stated it will not regulate software that estimates a patient’s future cardiovascular risk based on established clinical factors such as weight, current and historical smoking status, blood pressure and brain natriuretic peptide (BNP) in vitro diagnostic (IVD) test results.